# K190121: Ids SHBG

- Pathway: 510(k) (Traditional)
- Applicant: Immunodiagnostic Systems, Ltd.
- Decided: Jun 17, 2019 after 143 days
- Product code: CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone)
- Device class: 1
- Regulation: 21 CFR 862.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K924862 (1992). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151986: ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material, Siemens Healthcare Diagnostics, Inc. (2016) Summary page 5.

## Indications for use
The IDS SHBG assay is an in vitro diagnostic device intended for the quantitative determination of SHBG in human serum or plasma on the IDS System. Results are to be used as an aid in the diagnosis of androgen disorders

Source page: https://510kreport.com/device/K190121
Methodology: https://510kreport.com/methodology